跳至主要内容
临床试验/NCT03347721
NCT03347721Unknown4 期

Does Lidocaine Gel Decrease Pain Perception in Women Undergoing Diagnostic Flexible Cystoscopy?

Louisiana State University Health Sciences Center in New Orleans1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2016年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
129
试验地点
1
主要终点
Pain and satisfaction

研究概览

简要总结

This study is to determine if there is a clinically meaningful difference in pain perception for women during in-office diagnostic flexible cystoscopy when using lidocaine gel vs plain lubricant. This will be a double blinded randomized control trial.

详细描述

The use of anesthetic lubricant during in-office flexible cystoscopy has been well studied men. Pain during cystoscopy can lead to poor compliance and follow-up. Very few studies challenging the use of anesthetic lubricant during cystoscopy have included women. Those that have, only recruited a small number with insignificant findings. A meta-analysis reviewed four studies looking at the efficacy of lidocaine gel on pain relief during flexible cystoscopy in men. Four hundred and eleven men underwent flexible cystoscopy with and without the use of lidocaine gel and those who received anesthetic gel were 1.7 times more likely not to experience moderate to severe pain than those who received placebo. The anatomy of the female and male urogenital tract differ. The female urethra is approximately 3cm in length while the male urethra averages 7 cm with an external and prostatic sphincter which is the location where the most discomfort is thought to occur. A randomized control trial of 144 women undergoing rigid cystoscopy and found that pain was decreased with lidocaine vs placebo, however other studies such found no difference in pain perception. The efficacy of lidocaine gel in women during flexible cystoscopy has not been studied. The use of lidocaine gel during diagnostic flexible cystoscopy in women is based on surgeon preference and experience, and use of either plain or anesthetic gel, is currently acceptable clinical practice. The morbidity and cost of local anesthesia associated with cystoscopy in women is unknown due to the lack of studies. The objective of this study is to determine if there is a clinically meaningful difference in pain perception in women during in-office diagnostic flexible cystoscopy when using lidocaine gel vs plain lubricant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • need for in office diagnostic flexible cystoscopy

排除标准

  • urethral stricture
  • simultaneous scheduling or performed additional procedure
  • current urinary tract infection
  • hypersensitivity to local anesthetic of amide type

研究组 & 干预措施

Lidocaine gel

Active Comparator

干预措施: lidocaine gel (Drug)

Lubricant Gel

Placebo Comparator

干预措施: Lubricant Gel (Drug)

结局指标

主要结局

Pain and satisfaction

时间窗: Recorded immediately after the procedure

Composite of pain and satisfaction as determined by a Numeric Rating Scale for pain (validated measure) rating pain, as well as answers to yes or no questions asking if patient would repeat procedure in same method and if pain medicine is needed at end of procedure.

次要结局

  • Anticipated pain(Recorded prior to procedure at time of enrollment into study (anticipated) and immediately after procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erin Dougher

Principal Investigator

Louisiana State University Health Sciences Center in New Orleans

研究点 (1)

Loading locations...

相似试验